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NCT Number: NCT05321537

Comparison of Somatosensory Versus Endurance-strength Exercise in Patients With Chronic Neck Pain

Aim: To compare the effects of somatosensory exercise vs endurance-strength exercise on the deep cervical flexor muscles on pain and perceived disability in patients with chronic neck pain.

Study design: Protocol of a clinical trial, controlled, parallel and a blinded assessor.

Population: Subjects aged 18 to 65 years with neck pain of 3 or more months of evolution.

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Key information

Conditions

Neck Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alcalá

Alcalá de Henares, Madrid, 28801, Spain

About this study

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. A total of 60 subjects with nonspecific chronic neck pain will be selected and randomly assigned into two intervention groups. The first group will perform a somatosensory exercise program and a second group will perform activation and endurance-strength exercises of the deep cervical flexors. The duration of the intervention will be 8 weeks, with 6 sessions of physical therapy and daily home exercise. The variables pain, pressure pain threshold, disability, endurance-strength, proprioception, quality of life, kinesiophobia, quality of sleep and depression will be analyzed. Measurements will be taken pre-treatment, post-treatment and a follow-up at 3 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects of age between 18 and 65 years
  • Neck pain of 3 or more months of evolution

Exclusion criteria

  • Cervical Disability Index less than 15/50
  • Infection
  • Oncological processes
  • Neck or arm surgery
  • Neck or arm trauma
  • Positive neurological signs
  • Rheumatic diseases

Treatment and study plan

therapeutic exercises

Other

A somatosensory training and an endurance-strength training protocol

Primary outcomes

  1. Pain change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    To assess pain, the Visual Analogue Scale will be used, which consists of a 10-centimeter horizontal line, at whose ends is the maximum expression of a symptom.

  2. Disability change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    Disability will be assessed using the validated Spanish version of the Cervical Disability Index. Its range score is 0-50, higher values mean greater disability.

Secondary outcomes

  1. Pressure Pain Threshold change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    To assess the Pressure Pain Threshold, a analog pressure algometer will be used. The pressure will be performed bilaterally on the levator scapulae, upper trapezius, splenius capitis and sternocleidomastoid.

  2. Endurance of craniocervical flexion change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    The isometric endurance of the deep flexor muscles of the neck will be measured with the Craniocervical Flexion Test, using a pressure biofeedback.

  3. Proprioception change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    The proprioception of the head and neck in space will be evaluated using the Cervical Joint Positioning Error Test.

  4. Kinesiophobia change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    The patients' level of fear of movement will be evaluated using the Tampa Scale for Kinesiophobia. Range score is 11-44, higher values mean greater fear of injury.

  5. Sleep quality change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    To assess sleep quality we will use the Pittsburgh Sleep Quality Index, using the Spanish version. Range score is 0-21, higher values mean worse outcome.

  6. Quality of life change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    Quality of life will be assessed with the 12-Item Short Form Survey, second version (SF-12v2), using its Spanish version. This questionnaire is made up of 12 items which measure both physical and mental items. Range score is PCS 24-56,6 and MCS 19-60,8, higher values mean higher quality of life.

  7. Depression change

    Time frame: Pre-intervention, post-intervention (2 months) and follow-up of 3 months after the end.

    To assess depression, the Beck Depression Inventory in its second edition (BDI-II), in its Spanish version, will be used. Range score is 0-63, higher values mean worse outcome.

Sponsors and collaborators

Lead sponsor

Alexander Achalandabaso

Other

Registry information

Official study title

Comparison of Somatosensory Exercise Versus Endurance-strength Exercise in Patients With Chronic Neck Pain: a Randomized Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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